Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoiet… (NCT03602599) | Clinical Trial Compass
CompletedNot Applicable
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
United States190 participantsStarted 2018-11-15
Plain-language summary
Background:
This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more serious issues. Researchers want to study changes in the mouth that might indicate cGVHD.
Objective:
To identify cGVHD in the mouth and better understand the development, treatment, and progress of post-transplant changes in the mouth.
Eligibility:
Adults at least 18 years old who will soon undergo HSCT or have had one in the past 3 years Healthy adults at least 18 years old
Design:
All participants will have a screening visit and baseline visit. They will last 60-90 minutes. Over these two visits, participants will have:
Medical and dental history
Dental exam.
Questions about their eating habits and general health
Blood drawn through a needle in the arm
Vital signs taken
Pictures of their mouth and lips taken
Questions about their oral health, including about pain, sensitivity, or dryness
Saliva samples taken. Participants will spit into a sterile plastic tube.
Swabs taken of the mouth and some of the saliva, plaque, and fluid from the spaces between teeth and gums.
Participants may also have:
A piece of skin taken (biopsy) from the inner lining of the cheeks
A piece of skin taken (biopsy) from the lower lip
Dental X-rays
Urine pregnancy test
Most participants will have at least 7 study visits over 3 years. They will meet with a dentist and repeat baseline tests.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Subjects in Cohort NT and Cohort PT must satisfy all of the following criteria in order to participate in the study:
* Scheduled to undergo allogeneic HSCT at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant
* Willing to participate in protocol evaluations including saliva collection, oral swab collection, and completion of patient-reported outcome (PRO) forms
* Willing to return to the NIH Dental Clinic for scheduled evaluations
* Be at least 18 years of age at screening
* Be able to understand and provide written informed consent
* Subjects in Cohort HL and Cohort HS must satisfy all of the following criteria in order to participate in the study:
* Willing to undergo oral exam and participate in Visit 1 protocol evaluations including saliva collection, oral swab collection and oral biopsies.
* Be at least 18 years of age at screening
* Be able to understand and provide written informed consent
* Potentially be age- and/or sex-matched with a transplant patient
* Subjects in Cohort HL must additionally be willing and able to return to the NIH Dental Clinic for scheduled visits across 1 year and participate in evaluations including saliva collection, oral swab collection, and completion of PRO forms
EXCLUSION CRITERIA:
* Subjects in any Cohort will be excluded if they are pregnant, as pregnancy can have a confound…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed and it was focused on studying how chronic graft-versus-host disease develops in the mouth over time rather than testing a treatment — does that mean there are no direct treatment benefits for me, and are there newer trials that came out of this research that I should look into instead?
2Since this was an observational study tracking oral cGVHD in people who already had allogeneic stem cell transplants, would my specific transplant history and current oral symptoms make me a good candidate for any follow-up studies that this research may have led to?
3The study included both transplant patients and healthy controls, so it was really about understanding the disease process — given that, what did researchers learn about early warning signs of oral cGVHD that might be relevant to monitoring my own condition?
4Because this trial was focused on building scientific knowledge rather than treating cGVHD, what are my current standard-of-care treatment options for oral cGVHD, and how do they compare to anything new that might be emerging from studies like this one?
5If I'm already experiencing oral symptoms after my allogeneic stem cell transplant, should I be seeing a specialist who focuses on oral graft-versus-host disease, and is there an active treatment trial you could refer me to based on what this kind of research has uncovered?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Advance understanding of chronic graft versus host disease (cGVHD) pathophysiology and generate hypotheses for future cGVHD studies by tracking the longitudinal development of cGVHD in the oral cavity.
Timeframe: 3 years from enrollment of last participant
Trial details
NCT IDNCT03602599
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)